Efficiency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of ACO

Last updated: April 12, 2018
Sponsor: Huashan Hospital
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT03504527
KY2017-008
  • Ages 18-80
  • All Genders

Study Summary

This study evaluates the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium) in the treatment of acute exacerbation of asthma-chronic obstructive pulmonary overlap. Half of participants will receive budesonide,formoterol and tiotropium in combination, while the other half will receive budesonide and formoterol only.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • subject has ACO

Exclusion

Exclusion Criteria:

  • acute exacerbation of ACO;

  • acute infection;

  • postbrochodilator FEV1/FVC> 0.7;

  • pulmonary complications: bronchiectasis, active tuberculosis, pulmonary fungal diseaseor lung cancer

  • history of other malignant tumor

  • with rheumatic diseases;

  • with some serious heart, cerebrovascular, liver, kidney or hematopoietic systemdiseases

  • with tachyarrhythmias；

  • mental patients;

  • with moderate to severe renal insufficiency (creatinine clearance ≤ 50ml / h)

  • allergic to the budesonide, formoterol or tiotropium bromide;

  • history of acute gastrointestinal bleeding within 3 months;

  • with severe angle closure glaucoma patients;

  • pregnancy,lactation;

  • have participated in other clinical trials in 3 months；

  • hospital staff and their relatives

Study Design

Total Participants: 120
Study Start date:
May 01, 2018
Estimated Completion Date:
May 01, 2019

Study Description

ACO(asthma-chronic obstructive pulmonary overlap) is a relatively new proposed clinical form of chronic airway disease. Guideline or preferring therapy for ACO is still evolving. Current clinical solution is when ACO presents like asthma, initial treatment will accord to the guideline for asthma , while it presents like COPD, COPD recommendation treatment (not alone ICS,but ICS in addition of LABA with or without LAMA) will be chosen, which are subjective. Although present guidelines has recommended that ACO should be treated with at last two inhalant, but limited date have proven it.

A random controlled trial will be conducted to evaluate the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium bromide) in the treatment of acute exacerbation of ACO,compared with the control group receiving tiotropium bromide with formoterol only.